FIT Pro

GUDID 00850013900305

FIT Pro Breast Pump

HYGEIA II MEDICAL GROUP INC

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• Primary Device ID: 00850013900305
• NIH Device Record Key: 6743a7a6-e59d-406a-8722-43bffb0cda59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT Pro
• Version Model Number: 10-0309
• Company DUNS: 033147467
• Company Name: HYGEIA II MEDICAL GROUP INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013900305 [Primary]

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by HYGEIA II MEDICAL GROUP INC

• 00850013900305 - FIT Pro: 2023-08-09FIT Pro Breast Pump
• 00850013900305 - FIT Pro: 2023-08-09 FIT Pro Breast Pump
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• 00860001425253 - Evolve Breast Pump: 2019-07-01 Evolve Cordless Breast pump, PAS, Power supply
• 00860001425260 - Evolve: 2019-07-01 Evolve Breast Pump, pump only
• 00860001425277 - Evolve Breast Pump: 2019-07-01 Evolve Breast Pump, pump & Power Supply
• 00860001425284 - Evolve Breast Pump: 2019-07-01 Evolve Breast Pump, pump & Power Supply